New Drug Applications and 505(b)(2) Applications
This chart tracks the date, drug, reference-listed company, and applicant of Abbreviated New Drug Applications and 505(b)(2) Applications receiving final approval by the FDA.
| Approval Date | Reference Listed Drug | Generic Drug Name | NDA Holder | ANDA Applicant |
|---|---|---|---|---|
| 4/1/2022 | Permitil | Fluphenazine HCl | Schering | TWi Pharms |
| 4/4/2022 | Combigan | Brimonidine Tartrate / Timolol Maleate | AbbVie | Sandoz |
| 4/5/2022 | Paraflex | Chlorzoxazone | Johnson & Johnson | Rising |
| 4/6/2022 | Frova | Frovatriptan Succinate | Endo | Renata |
| 4/6/2022 | BiDiL | Isosorbide Dinitrate / Hydralazine HCl | Azurity | Riconpharma |
| 4/7/2022 | Noxafil | Posaconazole | Merck | Dr Reddy's |
| 4/7/2022 | Ganirelix | Ganirelix Acetate | Organon | Amphastar Pharms |
| 4/7/2022 | Bystolic | Nebivolol HCl | AbbVie | Prinston |
| 4/7/2022 | Allzital/Butapap | Butalbital / Acetaminophen | Larken / Mikart | Senores Pharms |
| 4/7/2022 | Vimpat | Lacosamide | UCB | Indoco |
| 4/8/2022 | Emla | Lidocaine / Prilocaine | Teva | Aleor Dermaceuticals |
| 4/8/2022 | Elcys | Cysteine HCl | Exela | Dr Reddy's |
| 4/11/2022 | Lexiscan | Regadenoson | Astellas | Apotex |
| 4/11/2022 | Lexiscan | Regadenoson | Astellas | Hong Kong |
| 4/11/2022 | Lexiscan | Regadenoson | Astellas | Dr Reddy's |
| 4/11/2022 | Lexiscan | Regadenoson | Astellas | Accord Healthcare |
| 4/11/2022 | Dotarem | Gadoterate Meglumine | Guerbet | Hengrui Pharma |
| 4/11/2022 | Sutent | Sunitinib Malate | Pfizer | Dr Reddy's |
| 4/12/2022 | Alphatrex | Betamethasone Dipropionate | Savage | Padagis |
| 4/13/2022 | Intelence | Etravirine | Johnson & Johnson | Carnegie |
| 4/14/2022 | Tikosyn | Dofetilide | Pfizer | Vgyaan |
| 4/14/2022 | Prolixin | Fluphenazine HCl | BMS | Taro Pharm |
| 4/14/2022 | Akovaz | Ephedrine Sulfate | Exela | Mankind Pharma |
| 4/15/2022 | Tikosyn | Dofetilide | Pfizer | Teva |
| 4/15/2022 | Dacogen | Decitabine | Otsuka | Jiangsu Hansoh Pharm |
| 4/15/2022 | Vibisone | Cyanocobalamin | Fresenius Kabi | Zydus |
| 4/15/2022 | Vibisone | Cyanocobalamin | Fresenius Kabi | Welding |
| 4/15/2022 | Carafate | Sucralfate | Allergan | Amneal Pharms |
| 4/15/2022 | Dotarem | Gadoterate Meglumine | Guerbet | Hengrui Pharma |
| 4/19/2022 | Mestinon | Pyridostigmine Bromide | Bausch | Milla Pharms |
| 4/19/2022 | Doxepin HCl | Doxepin HCl | Pfizer | Edenbridge Pharms |
| 4/20/2022 | Combigan | Brimonidine Tartrate / Timolol Maleate | AbbVie | Apotex |
| 4/20/2022 | Thiamine HCl | Thiamine HCl | Fresenius Kabi | Eugia Pharma |
| 4/21/2022 | Akovaz | Ephedrine Sulfate | Exela | Aggrega |
| 4/21/2022 | Olux | Clobetasol Propionate | Mylan | Aleor Dermaceuticals |
| 4/22/2022 | Xtandi | Enzalutamide | Astellas | Apotex |
| 4/22/2022 | Vitamin K1 | Phytonadione | Hospira | Cipla |
| 4/26/2022 | Seroquel XR | Quetiapine Fumarate | AstraZeneca | Prinston |
| 4/27/2022 | Ranexa | Ranolazine | Gilead | I3 Pharms |
| 4/27/2022 | Targretin | Bexarotene | Bausch | Amneal |
| 4/28/2022 | Esbriet | Pirfenidone | Genentech | Sandoz |
| 4/28/2022 | Taytulla | Norethindrone Acetate / Ethinyl Estradiol / Ferrous Fumarate | Apil | Mayne Pharma |
| 4/29/2022 | Intal | Cromolyn Sodium | King | Micro Labs |
| 4/29/2022 | Imdur | Isosorbide Mononitrate | Schering | Shandong |
| 5/2/2022 | Velcade | Bortezomib | Takeda | Apotex |
| 5/2/2022 | Velcade | Bortezomib | Takeda | Teva |
| 5/2/2022 | Velcade | Bortezomib | Takeda | Sagent / Pharmascience |
| 5/2/2022 | Velcade | Bortezomib | Takeda | Fresenius Kabi |
| 5/2/2022 | Velcade | Bortezomib | Takeda | Zydus |
| 5/2/2022 | Velcade | Bortezomib | Takeda | Ingenus / Qilu Pharm Hainan |
| 5/2/2022 | Velcade | Bortezomib | Takeda | Eugia Pharma |
| 5/2/2022 | Velcade | Bortezomib | Takeda | Baxter Healthcare |
| 5/2/2022 | Tamiflu | Oseltamivir Phosphate | Roche | MSN |
| 5/3/2022 | Lyrica | Pregabalin | Pfizer | Lupin |
| 5/3/2022 | Zyflo CR | Zileuton | Chiesi | Teva |
| 5/3/2022 | Vimpat | Lacosamide | UCB | Fresenius Kabi |
| 5/3/2022 | Abreva | Docosanol | Glaxo | Aleor Dermaceuticals |
| 5/3/2022 | Zinc Sulfate | Zinc Sulfate | American Regent | Gland Pharma |
| 5/4/2022 | Pomalyst | Pomalidomide | Celgene | Teva |
| 5/4/2022 | Flomax | Tamsulosin HCl | Sanofi | Acme Labs |
| 5/5/2022 | Fanapt | Iloperidone | Vanda Pharms | Lupin |
| 5/5/2022 | Ranexa | Ranolazine | Gilead | Hetero Labs |
| 5/5/2022 | Northera | Droxidopa | Lundbeck | Celltrion |
| 5/5/2022 | Xylocaine | Lidocaine HCl | Fresenius Kabi | Sintetica |
| 5/5/2022 | Tiazac | Diltiazem HCl | Bausch | Mayne Pharma |
| 5/6/2022 | Pennsaid | Diclofenac Sodium | Horizon | Apotex |
| 5/6/2022 | Apriso | Mesalamine | Valeant | Teva |
| 5/9/2022 | Vfend | Voriconazole | PF Prism | Meitheal |
| 5/10/2022 | Norvir | Ritonavir | AbbVie | Cipla |
| 5/10/2022 | Synthroid | Levothyroxine Sodium | AbbVie | Teva |
| 5/10/2022 | Daliresp | Roflumilast | AstraZeneca | Prinston |
| 5/10/2022 | Noxafil | Posaconazole | Merck Sharp Dohme | Specgx |
| 5/10/2022 | Brovana | Arformoterol Tartrate | Sunovion | Alembic Pharms |
| 5/10/2022 | Sabril | Vigabatrin | Lundbeck | Aurobindo |
| 5/11/2022 | Requip XL | Ropinirole HCl | GlaxoSmithKline | Prinston |
| 5/11/2022 | Pentasa | Mesalamine | Takeda | Sun Pharm |
| 5/11/2022 | Cataflam | Diclofenac Potassium | Amici | Umedica Labs |
| 5/13/2022 | Nicorette | Nicotine Polacrilex | GlaxoSmithKline | Aurobindo |
| 5/13/2022 | Kuvan | Sapropterin Dihydrochloride | Biomarin | Dr Reddy's |
| 5/16/2022 | Bijuva | Estradiol / Progesterone | TherapeuticsMD | Amneal |
| 5/17/2022 | Butrans | Buprenorphine | Purdue | Alvogen |
| 5/18/2022 | Protonix IV | Pantoprazole Sodium | Wyeth | Gland Pharma |
| 5/18/2022 | Trilafon | Perphenazine | Schering | Appco |
| 5/18/2022 | Vantin | Cefpodoxime Proxetil | Pharmacia / Upjohn | Alkem Labs |
| 5/18/2022 | Esbriet | Pirfenidone | Genentech | Micro Labs |
| 5/18/2022 | Protonix IV | Pantoprazole Sodium | Wyeth | Aspiro |
| 5/18/2022 | Protonix IV | Pantoprazole Sodium | Wyeth | Be Pharms |
| 5/19/2022 | Letairis | Ambrisentan | Gilead | Apotex |
| 5/19/2022 | Visapaque | Iodixanol | GE Healthcare | Hengrui Pharma |
| 5/19/2022 | Vimpat | Lacosamide | UCB | Alkem Labs |
| 5/19/2022 | Protonix IV | Pantoprazole Sodium | Wyeth | Knack |
| 5/20/2022 | Esbriet | Pirfenidone | Genentech | Alembic Pharms |
| 5/20/2022 | Aromasin | Exemestane | Pfizer | Eugia Pharma |
| 5/23/2022 | Lexiscan | Regadenoson | Astellas | IMS |
| 5/24/2022 | Esbriet | Pirfenidone | Genentech | MSN |
| 5/24/2022 | Nimbex | Cisatracurium Besylate | AbbVie | Piramal |
| 5/24/2022 | Prilosec OTC | Omeprazole Magnesium | AstraZeneca | Perrigo |
| 5/25/2022 | Alimta | Pemetrexed Disodium | Eli Lilly | Fresenius Kabi |
| 5/25/2022 | Alimta | Pemetrexed Disodium | Eli Lilly | Hospira |
| 5/25/2022 | Alimta | Pemetrexed Disodium | Eli Lilly | Dr Reddy's |
| 5/25/2022 | Alimta | Pemetrexed Disodium | Eli Lilly | Accord Healthcare |
| 5/25/2022 | Alimta | Pemetrexed Disodium | Eli Lilly | Apotex |
| 5/25/2022 | Alimta | Pemetrexed Disodium | Eli Lilly | Qilu Pharm Hainan |
| 5/25/2022 | Alimta | Pemetrexed Disodium | Eli Lilly | Nang Kuang Pharm |
| 5/25/2022 | Alimta | Pemetrexed Disodium | Eli Lilly | Jiangsu Hansoh Pharm |
| 5/25/2022 | Alimta | Pemetrexed Disodium | Eli Lilly | Apotex |
| 5/25/2022 | Alimta | Pemetrexed Disodium | Eli Lilly | Biocon Pharma |
| 5/25/2022 | Alimta | Pemetrexed Disodium | Eli Lilly | Waverley Pharma |
| 5/25/2022 | Alimta | Pemetrexed Disodium | Eli Lilly | Zydus |
| 5/25/2022 | Alimta | Pemetrexed Disodium | Eli Lilly | Eugia Pharma |
| 5/25/2022 | Noxafil | Posaconazole | Merck | Par |
| 5/26/2022 | Orfadin | Nitisinone | Swedish Orphan | Medunik |
| 5/26/2022 | Zemuron | Rocuronium Bromide | Organon | Prinston |
| 5/26/2022 | Brovana | Arformoterol Tartrate | Sunovion | Sun Pharm |
| 5/26/2022 | Atropine Sulfate | Atropine Sulfate | Hospira | American Regent |
| 5/26/2022 | Bumex | Bumetanide | Validus | Gland Pharma |
| 5/27/2022 | Symmetrel | Amantadine HCl | Endo | Edenbridge Pharms |
| 5/27/2022 | Keppra | Levetiracetam | UCB | Sciegen Pharms |
| 5/27/2022 | Children's Motrin | Ibuprofen | Johnson & Johnson | Strides Pharma |
| 5/27/2022 | Minocycline HCl | Minocycline HCl | Triax | Beximco Pharms |
| 5/27/2022 | Keppra | Levetiracetam | UCB | Alkem Labs |
| 5/31/2022 | Vimpat | Lacosamide | UCB | Hetero Labs |
| 5/31/2022 | Epiduo Forte | Adapalene / Benzoyl Peroxide | Galderma | Padagis |
| 5/31/2022 | Concerta | Methylphenidate HCl | Johnson & Johnson | Rhodes Pharms |
| 5/31/2022 | Florinef | Fludrocortisone Acetate | Casper | Novitium Pharma |
| 5/31/2022 | Allegra-D | Fexofenadine HCl / Pseudoephedrine HCl | Sanofi | Dr Reddy's |
| 5/31/2022 | Advil PM | Ibuprofen / Diphenhydramine Citrate | GlaxoSmithKline | Aurobindo |
| 6/1/2022 | Aleve-D | Naproxen Sodium / Pseudoephedrine HCl | Bayer | Aurobindo |
| 6/2/2022 | Suboxone | Buprenorphine HCl / Naloxone HCl | Indivior | Aveva |
| 6/2/2022 | Thiola | Tiopronin | Mission | Par |
| 6/3/2022 | Epiduo Forte | Adapalene / Benzoyl Peroxide | Galderma | Zydus |
| 6/3/2022 | Pepcid | Famotidine | Johnson & Johnson | Zydus |
| 6/6/2022 | Lupron | Leuprolide Acetate | AbbVie | Eugia Pharma |
| 6/6/2022 | Potassium Chloride | Potassium Chloride | Genus Life Sciences | Wes Pharma |
| 6/6/2022 | Ganirelix | Ganirelix Acetate | Merck | Hong Kong |
| 6/6/2022 | Elavil | Amitriptyline HCl | AstraZeneca | Centaur Pharms |
| 6/7/2022 | Naprosyn | Naproxen | Atnahs Pharma | Hetero Labs |
| 6/7/2022 | Nexavar | Sorafenib Tosylate | Bayer | Dr Reddy's |
| 6/8/2022 | Kabilyte | Multiple Electrolytes Injection Type 1 USP Ph 7.4 | Baxter | Fresenius Kabi |
| 6/8/2022 | Tenex | Guanfacine HCl | Promius | TWi Pharms |
| 6/9/2022 | Glumetza | Metformin HCl | Santarus | Prinston Inc |
| 6/9/2022 | Narcan | Naloxone HCl | Adapt | Mylan |
| 6/9/2022 | Infants Advil Concentrated Drops | Ibuprofen | Glaxo | Strides Pharma |
| 6/9/2022 | Briviact | Brivaracetam | UCB | Sunshine |
| 6/9/2022 | Xylocaine | Lidocaine HCl | Fresenius Kabi | Afaxys |
| 6/10/2022 | Narcan | Naloxone HCl | Adapt | Hikma |
| 6/13/2022 | Esbriet | Pirfenidone | Genentech | Sandoz |
| 6/13/2022 | Procomp | Prochlorperazine Maleate | Jubilant Cadista | Biophore / Zenara |
| 6/14/2022 | Lovenox | Enoxaparin Sodium | Sanofi | Nanjing King-Friend |
| 6/14/2022 | Tranxene | Clorazepate Dipotassium | Recordati | Corepharma |
| 6/15/2022 | Isoptin | Verapamil HCl | Mt Adams | Mankind Pharma |
| 6/15/2022 | Vesicare | Solifenacin Succinate | Astellas | Annora Pharma |
| 6/16/2022 | Seroquel | Quetiapine Fumarate | AstraZeneca | Hetero Labs |
| 6/16/2022 | Nasalide | Flunisolide | Ivax | Riconpharma |
| 6/16/2022 | Tranxene | Clorazepate Dipotassium | Recordati | Novitium Pharma |
| 6/21/2022 | Bicnu | Carmustine | Avet Lifesciences | Ingenus Pharms |
| 6/21/2022 | Narcan | Naloxone HCl | Emergent | Padagis |
| 6/21/2022 | Gleevec | Imatinib Mesylate | Novartis | Qilu Pharm Hainan |
| 6/22/2022 | Epiduo Forte | Adapalene / Benzoyl Peroxide | Galderma | Actavis |
| 6/22/2022 | Sabril | Vigabatrin | Lundbeck | Amneal |
| 6/22/2022 | Carbaglu | Carglumic Acid | Recordati | Navinta |
| 6/22/2022 | Tarceva | Erlotinib HCl | Roche | Eugia Pharma |
| 6/23/2022 | Jevtana Kit | Cabazitaxel | Sanofi | Breckenridge |
| 6/23/2022 | Syprine | Trientine HCl | Bausch | Hetero Lab |
| 6/24/2022 | Amoxil | Amoxicillin | US Antibiotics | Micro Labs |
| 6/24/2022 | Yonsa | Abiraterone Acetate | Sunovion | Teva |
| 6/24/2022 | Timoptic-XE | Timolol Maleate | Bausch | Gland Pharma |
| 6/24/2022 | Sabril | Vigabatrin | Lundbeck | Elite Labs |
| 6/24/2022 | Sinequan | Doxepin HCl | Pfizer | MSN |
| 6/24/2022 | Nexium 24 Hr | Esomeprazole Magnesium | AstraZeneca | Graviti Pharms |
| 6/27/2022 | Amitiza | Lubiprostone | Sucampo | Par / Anchen |
| 6/27/2022 | Parnate | Tranylcypromine Sulfate | Concordia | CrossMedika |
| 6/27/2022 | Gastrografin | Diatrizoate Meglumine / Diatrizoate Sodium | Bracco | Guardian Drug |
| 6/28/2022 | Nimbex | Cisatracurium Besylate | AbbVie | Hikma |
| 6/28/2022 | Mysoline | Primidone | Bausch | Rubicon |
| 6/29/2022 | Invega | Paliperidone | Johnson & Johnson | Lupin |
| 6/29/2022 | Vimpat | Lacosamide | UCB | Zydus |
| 6/29/2022 | Epaned O.S. | Enalapril Maleate | Azurity | Amneal |
| 6/29/2022 | PlasmaLyte | Multiple Electrolytes Injection Type 1 USP Ph 5.5 | Baxter | Fresenius Kabi |
